A randomised trial of combination bleomycin, ifosfamide and cisplatinum versus single agent cisplatinum in recurrent cervical cancer
| ISRCTN | ISRCTN27785591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27785591 |
| ClinicalTrials.gov (NCT) | NCT00003209 |
| Protocol serial number | CE3004 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 04/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cervix |
| Intervention | 1. Arm A: Chemotherapy with single agent cisplatinum repeated every 21 days for a maximum of six courses. 2. Arm B: Multi-drug chemotherapy with bleomycin, ifosfamide and cisplatinum (BIP) repeated every 21 days for a maximum of six courses. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/02/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Key inclusion criteria | 1. Histologically proven recurrent invasive squamous cell carcinoma of the cervix uteri 2. Symptomatic inoperable pelvic or metastatic disease not amenable to local radiotherapy 3. No previous chemotherapy with any of the study agents 4. World Health Organisation (WHO) performance status >2 5. Adequate renal hepatic and haematological function 6. Adequate pulmonary function 7. Expected survival of >3 months 8. No second primary tumour other than basal cell carcinoma of the skin 9. No other serious medical or psychological condition precluding treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 28/02/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2000 | Yes | No |
